Scientists Simplifying Science

Sci-IP

Blogs about Intellectual Property and Regulatory Affairs

August 29, 2017: The Patent Chronicle is your go to destination for a capsule dose on the hottest happenings in the patent world. It is led by Syam Anand, who has been at the core of CSG’s development and an entrepreneur himself. In this section, Syam has clinically dissected out every news on the decision, the reason and the impact to help you comprehend the full story in a nutshell. He is also in the process of building his scicomm team for this section. If you would like to come aboard, mail him at syam.anand@sciwri.club

Decision: The US district court of Florida granted an injunction sought by the Federal Trade Commission (FTC) that extended a freeze on the assents of World Patent Marketing Inc. (WPM).

Reason: FTC had stepped in to stop WPM from a scam that cheated inventors of around 26 million USD. WPM had misrepresented facts to mislead customers with false success stories and promises to patent and market inventions. Further, they threatened consumers with criminal prosecution if they complained about their dissatisfaction with WPM’s services.

Impact: In March 2017, FTC had scored a win to freeze WPM’s assets. With the current win, the freeze has been extended. It takes FTC one step closer to return the money from WPM to its dissatisfied customers. WPM is one of the several companies that operate by promising patenting and marketing of inventions by requesting inventors to submit regular payments. News such as this, will not only put an end to this exploitation by WPM, but also open the eyes of inventors and innovators, when they seek such services.

PFIZER’S PNEUMONIA VACCINE INDIA PATENT SHOWS TWO SIDES OF A BAD COIN

Background: Prevenar 13, as the name indicates is effective against 13 pneumococcal strains. Pneumococcus, the responsible bug, has demonstrated the ability to evolve and cause infections in spite of widespread use of vaccines against the bug. This had pushed vaccine developers to keep adding more and more antigens to the vaccines in their efforts to obtain effective herd immunity. However, it appears that vaccination against Pneumococcal pneumonia is a loosing battle due to the strain variability of the bug. WHO had advised antibiotic treatment of Pneumococcal pneumonia as a more economically viable option since the bugs are largely sensitive to antibiotics.

Impact: The debate in India about the impact of the vaccine patent is on multiple fronts. First, there is the accessibility issue, as India is not eligible for GAVI (Global Alliance for Vaccines and Immunisation) because its per capita GDP exceeds the 1500$ cut off. This makes the vaccine expensive for India. Second, there is the issue of wrong priority if the Indian administration goes ahead with its intention to pursue procurement and distribution of the vaccine through its government medical centers instead of following WHO’s recommendation. Third, there is a local manufacturing issue, as India has a vibrant Pharmaceutical manufacturing industry that thrives on producing cheaper drugs and vaccines that puts them in direct competition with many multinational pharmaceutical giants. Fourth, there is fear among aid groups that the patent will act as a block for cheaper solutions although one wonders why they are not focusing more on the cheaper alternatives to vaccines that already exist for Pneumococcal pneumonia.

REGENERON PATENT INVALIDATED FOR INEQUITABLE CONDUCT

Decision: A Federal Circuit court decided that references withheld by Regeneron when filing the patent was “but-for” material, not cumulative and with the specific intent to deceive the PTO.

Background: Regeneron had sued Merus for infringement on a patent U.S. Patent No. 8,502,018. Merus appealed that the patent is unenforceable because of inequitable conduct that happened during the prosecution of the patent before USPTO. Merus alleged that Regeneron’s attorney withheld four references that they had an obligation to disclose to the PTO when they submitted the application for examination. USPTO rules state that representatives (in this case attorneys) have a duty to disclose all material known to them that are material to patentability of the invention covered in an application. Failure to do so is considered inequitable conduct.

Impact: The decision makes the Regeneron patent unenforceable. In inequitable conduct, a specific intent to deceive is a difficult thing to prove in the absence of direct evidence showing such intent. However, it appears that in this case the Court decided that there was specific intent based on a “pattern of misconduct” during litigation. Normally, such intent is sought among actions that occurred during prosecution of the application- the time during which attorneys submit documents to the PTO. It is likely that failure to provide documents and follow the directives of the court during litigation may soon be construed as proof for specific intent to deceive in other cases as well.

Infographically speaking….

Proprietary Humor

Authored by Dr Syam Anand, PhD (Indian Institute of Science, IISc; Post-Doctoral research, University of Pittsburgh School of Medicine; Faculty, University of Pittsburgh School of Medicine, Founder and US Patent Agent, Mainline Intellectual Property LLC, Ardmore, Philadelphia USA). Syam has over 20 years experience in diverse areas of Science with domain knowledge in Life Sciences and Intellectual Property. Dr. Anand is also an inventor and budding entrepreneur. A rationalist, Dr. Anand enjoys science at all levels and advocates the use of scientific methods for answering all questions and solving all problems and make common people curious and interested in understanding their worlds.

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August 1, 2017: Your weekly dose from the world of patents. The Patent Chronicle is led by Syam Anand, who has been at the core of CSG’s development and an entrepreneur himself. This section is your go to destination every week for a capsule dose on the hottest happenings in the patent world. Syam has clinically dissected out every news on the decision, the background and the impact. He is also in the process of building his scicomm team for this section. If you would like to come aboard, mail him at syam.anand@sciwri.club

The 1990 Nobel Prize for Doctors without Borders provided the seed money for DNDI. But that was not sufficient for DNDI to realize its goal of manufacturing and distributing drugs for diseases of the poor. Bernard Pécoul, a physician associated with Doctors without Borders embarked on a journey to realize this dream. Delinking the usual norms and practices of drugs and profitability, Pécoul lead DNDI to a pharma company for the poor. DNDI now delivers patent-free drugs to neglected diseases that would not have been possible with complete reliance on traditional pharmaceutical industry.

A life-saving patent that Volvo never licensed

US Patent 3043625 to Nils Bohlin reduced the fatalities from car collisions by almost 50%. Volvo, with whom Bohlin was employed was also a leader in many safety features that we use in cars even today. But little known is the fact that Volvo allowed all car manufacturers to use their patented three-point harness system without requiring a license. Thank Bohlin and Volvo for the “click it”.

Exon-skipping patent settlement by Sarepta

Reason: Worldwide patent battles had pitched the two companies against one another on the use of exon-skipping products for DMD.

Impact: Both Biomarin and Sarepta come out as winners with agreements on royalties, licensing fees and profit sharing. They are also a sign of mutual cooperation that will benefit the end-users. As a result of these agreements, both companies get credit for their innovation, which will allow them to focus on R&D rather than litigation. It also consolidates their position as a global leader in exon-skipping products for diseases like DMD.

Stryker strikes triple damages

Decision: US district judge ruled that Zimmer Biomet infringed Stryker’s patent for a pulsed lavage system used in surgeries. Further, the court tripled the damages for infringement for egregious behavior.

Reason: The infringement suit was filed in 2010 in Kalamazoo and related to three patents covering Stryker’s Pulsavac. The litigation also took place in the federal circuit with mixed results for Stryker. The judge in Michigan however felt that Zimmer did nothing to stop the infringing activity or mitigate damages at any point during the litigation. Further, the judge also felt that the Zimmer refused to turn over the evidence in a “willful and egregious” manner.

Impact: As a result of the judgment Zimmer owes Stryker 248.7 million dollars. It is a good time to be associated with Stryker.

Amphastar gets breather in blood thinner war

Decision: The US District court jury in Boston ruled that a Momenta patent used to test an ingredient in generic Lovenox is invalid. The jury also sided with Amphastar on whether Momenta had waived its rights to enforce the patent.

Reason: Momenta and Novartis had sued Amphastar close to a billion dollars in lost sales for using their patented test without permission in the manufacture of their generic version.

Impact: Lovenox has a long history of litigation. The legal war will continue on multiple fronts with Amphastar filing an antitrust motion against Momenta and Momenta planning for appeals.

Infographically speaking….

Proprietary Humor

Authored by Dr Syam Anand, PhD (Indian Institute of Science, IISc; Post-Doctoral research, University of Pittsburgh School of Medicine; Faculty, University of Pittsburgh School of Medicine, Founder and US Patent Agent, Mainline Intellectual Property LLC, Ardmore, Philadelphia USA). Syam has over 20 years experience in diverse areas of Science with domain knowledge in Life Sciences and Intellectual Property. Dr. Anand is also an inventor and budding entrepreneur. A rationalist, Dr. Anand enjoys science at all levels and advocates the use of scientific methods for answering all questions and solving all problems and make common people curious and interested in understanding their worlds.

Prity Khastgir is a techno-savvy patent attorney in India with 12 yrs of experience working with clients across the globe. Her areas of expertise are IP portfolio research, cross-border technology transactions, licensing agreements, product clearance, freedom-to-operate, patent infringement & invalidity analysis, research & opinions. Currently, she helps startups to raise funds, assists foreign companies to find right business partners in India. She also assists enterprises to enter and find the right angels, and VCs in Malaysia, Singapore, US, UK, Japan and India. Here, she answers questions about IP career prospects in India, in her Face-to-face interaction with Reetu Mehta.

Is Intellectual Property Rights (IPR) a good career option in India?

Before answering this question, I ask myself why I do what I do every morning. Am I passionate about my day? IPR is a fascinating field and apt for people who wants answers to questions related to what, why, when and how. IPR is a field of law protecting creations of mind in form of ideas, inventions, brands, trademarks, copyrights, software codes, industrial design registration and trade secrets. However, if research is not your cup of tea then please do not enter this field. You have to passionate about innovations. Many people enter this field because it is a high paying job in the long run compared to normal 9-5 jobs in India. However, not everyone will be able to sustain in this field in the long run. Therefore, be wise before entering this field. You should be fascinated by technologies around you, have a problem solving approach, and be compassionate towards your peers.

Life science is study of life processes. The scope of PhD in IPR is better as the person is familiar with research. The best way to move forward is to do online IPR courses and get an overview of IPR. One should have interest and passion to solve the queries related to the intellectual creations of mind. One should have problem solving approach as client is looking for solutions.

First and foremost, the person should have technology and legal acumen to understand innovations and have a research capability to work at least for 10-12 hours. Thinking out of the box to solve a research project is the key to assisting inventors to protect their inventions.

How does a career in IP evolve/grow in India?

The individuals I have come across are passionate about protecting innovations. To evolve in this field you have to be technology savvy. The Intellectual Property law has evolved a lot in last 10 years. Now a trademark can be registered in less than one month in India with proper documentation. The Indian government is giving a number of grants to startups in India to grow by leap and bounds.

What is the kind of work one is expected to do and what are the skill sets one can acquire over the course?

Reviewing and researching similar technologies filed across global patent websites. IPR rights are territorial in nature, which means if a patent is protected in India and not in US then anybody is free to use the technology in the US. A patent is granted to a technology that is new, non-obvious to an expert in the same field, and have industrial applicability. Right from patent filing before the patent office to patent grant, a number of steps are executed by a number of patent associates. Apart from this, a patent expert can research and work on a number of projects related to foreign patent litigation cases, which is an excellent knowledge process outsourcing model thriving in India.

How was your journey in IPR? What is required for a fulfilling and enjoyable IP career?.

My career has been a roller coaster. I always wanted to do something different in life. I am passionate about everything, which comes my way. Everyday is an opportunity to learn something new. I strongly believe that knowledge is power and to be a successful human being one has to update knowledge on a regular basis. So many innovations are happening on a daily basis. It is next to impossible to learn everything but I make it a point to read at least ten granted patents in different domains. I personally believe that there is so much to learn from every person. I graduated in Applied Science (honours) from Delhi University. I was fortunate to learn from the best teachers in Delhi University and they are like family to me. I did my masters in Biotechnology and fortunate to clear Patent Agent Examination at the age of 21 years. I am a 10K Goldman Sachs scholar from ISB, Hyderabad and legal counsel at BIMTECH, Greater Noida, India. The last 12 years has been a memorable experience and I have worked more than 30,000 hours and the learning has been memorable and incredible. The learning curve in intellectual property domain is exponential and with every project I learn so much about what kind of research is happening in any technology domain across the globe.

Where do you think your future will be in 5, 10 years from now?

Well I believe in short-term and long-term goals. My short-term goal is to start an incubation centre focusing on developing untapped intellectual property portfolio from domestic and foreign startups in India. We have already started one centre in Aerocity, New Delhi, India. On a personal front, I intend to join politics and work in developing a holistic intellectual property ecosystem in India, which will help India to become a developed country. 10 years from now, I see India as a developed country and of course I would be part of the Indian Government.

What is the profile of people who practice IP In India, for example, Engineers, Science grads, and Law degree holders? How do they like it? What made them come to IPR?

The current profile is very diverse. The well-known and top IP firms are run by lawyers who don’t have a technical background as the patent law was introduced in India in 1970. Post 2005, the law was amended and a science degree became compulsory to sit for the examination. There is a gap in the industry that needs to be fulfilled. Lawyers are not very sound with technical understanding of patents and science graduates and post-graduates are not conversant with legal law practice. The field is very lucrative as the demand of good skilled professionals is the need of the hour.

To bridge this gap we are starting with autonomous patent law and practice course for individuals in near future. The job prospect in the current scenario is very different as compared to early 2000’s. To cater to the future need of IP based companies in India, we will need techno-legal patent professionals.

Does the growth trajectories differ based on the basic qualification? For example, in the US, a PhD is almost a must, how is it in India?

We can’t compare US patent law with Indian patent practice. India is at least 50 years backward when we compare with the US patent law. I have personally worked on more than 500+ different technologies in my career span of 12 years for US-based business entities. Those technologies will not even enter India before 2050. Having said that, we don’t need PhD as the basic requisite for working in IP field. Of course having a PhD degree is advantageous for companies who are focusing on two to three verticals. The most important point to be considered for working in patent domain is the passion to understand technologies and do research which might be boring for a PhD who is more inclined to wet laboratory research.

For an IP assignment whom all do you interact with and what are the kind of clients do you get to work with? How do they pay and sustain their funding? How does that affect your growth? For example in the US, patent agents can end as partners.

On a personal front I am an entrepreneur at heart. We have association with more than 100+ law firm partners across the globe. The best part of working with IP professionals across the globe is you are never out of work. For example, year-end is holiday season in USA. However, the Chinese market is still working in those months. Chinese New Year is in the month February. So we work with clients across all domains. Sometimes US companies engage us for patent litigation research work. We are one stop solution provider for providing customized patent research work according to clients need. Therefore, we work with Fortune 100 companies at one end and on the other end we work with startups and individual inventors.

We generally take upfront payments for all our projects. Our growth path is exponential and we believe in innovating from ground level. Thinking out of the box is the key to sustain with the big patent law firms in India. We don’t compete with any firm or KPO unit in India. We believe in creating our own path by identifying weak points existing in the current ecosystem.

Where is Indian IPR with respect to the rest of the world? Where does it plan to go? How does it fare with respect to other countries (for example BRIC)? Can Indian IPR folks work for Universities, Equity firms, Market analysts etc.?

Of course, the Indian IPR folks can work for Universities, Equity firms, and as Market Analysts for domestic and global companies. I personally think Indian Patent Law and enforcement is very weak in India. We don’t have IP experts in government organizations. A lot has to be changed as far as government polls are concerned and that is my reason of joining politics in near future. India needs to sign different treaties to expedite the patent grant processes in India. India should learn from neighbouring countries like Singapore and Malaysia where patent prosecution highway is on the rise and friendly for foreign companies at the same time. When India is compared with BRIC countries, India has to sign more treaties and hire more patent examiners to take care of the backlog of the patent applications at the Indian Patent Office.

About the Author:Reetu Mehta did her PhD in microbial genetics, in studying the genetic mechanism determining enteric production. Currently, she is utilizing her scientific training in analyzing intellectual property and works for as a Lead Analyst at Tracxn.

About the Editor:

Edited by Dr Syam Anand, PhD (Indian Institute of Science, IISc; Post-Doctoral research, University of Pittsburgh School of Medicine; Faculty, University of Pittsburgh School of Medicine, Founder and US Patent Agent, Mainline Intellectual Property LLC, Ardmore, Philadelphia USA). Syam has over 20 years experience in diverse areas of Science with domain knowledge in Life Sciences and Intellectual Property. Dr. Anand is also an inventor and budding entrepreneur. A rationalist, Dr. Anand enjoys science at all levels and advocates the use of scientific methods for answering all questions and solving all problems and make common people curious and interested in understanding their worlds.

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July 11, 2017: Your weekly dose from the world of patents. The Patent Chronicle is led by Syam Anand, who has been at the core of CSG’s development and an entrepreneur himself. This section is your go to destination every week for a capsule dose on the hottest happenings in the patent world. Syam has clinically dissected out every news on the decision, the background and the impact. He is also in the process of building his scicomm team for this section. If you would like to come aboard, mail him at syam.anand@sciwri.club

Broad submits CRISPR patents to MPEG LA Pool

Decision: Broad Institute and its collaborators submitted all their CRISPR patents to MPEG LA LLC, a Colorado firm that specializes in creation of patent pools for licensing.

Impact: The submission of Broad CRISPR patents is a sign that the Institute and its collaborators are willing to make licensing of the technology easier for potential end-users and also share the proceeds from CRISPR technology. It is not clear whether UC Berkeley that enjoyed a wining streak in CRISPR patents in various national patent offices is also planning to join the pool. If it does, it will prevent potential users from having to obtain separate licenses from various entities that own the rights to the technology.

Canada rejects the Promise Doctrine

Decision: A Canadian Supreme Court ruled that the Promise doctrine that may be used to invalidate a patent if it does not do everything it promises it will do, goes too far.

Reason: Apotex had sought to invalidate an Astra Zeneca patent using the doctrine as an arguing point. The court rejected Apotex’s argument and held that a “scintilla of utility” is sufficient and further that a single-use related to the subject matter was sufficient. In other words, not everything that is claimed has to work for a patent to be valid, just one would suffice to clear the utility threshold.

Impact: The ruling is a boon to patent owners. It makes Canadian IP law more predictable and will reduce litigations in Canada stemming from the controversial doctrine that put a higher threshold for Canadian patents vs. patents in the rest of the world. Canada was an outlier in this respect and cost patent owners. The doctrine was also a major irritant for US-Canada trade talks. Earlier, NAFTA had refused to intervene in a matter related to the doctrine brought in front of the agency by Eli Lily. The ruling clears the air for such cases in front of NAFTA too.

Decision: The Supreme Court of Canada upheld a ruling by a lower court that ordered Google to remove the website of a company that sold infringing products on its website.

Reason: Equustek had sued Datalink for infringement and won. Equustek also had an injunction against Google to remove Datalink websites from global search results. Google did not completely stop Datalink from appearing in the searches. Google argued that the injunction violated freedom of expression. The court held that Google actions were “determinative” in causing harm to Equustek. The court made it clear that freedom of expression does not require facilitation of the unlawful sale of goods, and violation of several court orders.

Impact: The ruling could set an international precedent in protecting intellectual property rights as it directly lays out the responsibilities of service providers. It will force them to take affirmative steps to prevent unlawful sales that affect rightful owners of IP. Organizations involved in civil liberties and freedom of expression rights are afraid that the ruling can set a wrong precedent.

Abbvie’s Humira patent troubles increase

Decision: In an intra partes review brought by Boehringer Ingelheim, the USPTO’s PTAB invalidated five claims in a key Abbvie patent that covered Humira.

Reason: PTAB found that the claims are obvious in light of various combinations of publications that predate the patent.

Impact: Abbvie will face big competition from biosimilars who continue to score wins against Humira. Coherus Biosciences, Samsung Bioepis, Biogen, and Amgen are continuing to chip away at Humira’s exclusivity and patent rights in many parts of the world. As Humira is a major revenue source for Abbvie (60%), Abbvie is looking to diversify.

Infographically speaking…..

Proprietary Humor

Authored by Dr Syam Anand, PhD (Indian Institute of Science, IISc; Post-Doctoral research, University of Pittsburgh School of Medicine; Faculty, University of Pittsburgh School of Medicine, Founder and US Patent Agent, Mainline Intellectual Property LLC, Ardmore, Philadelphia USA). Syam has over 20 years experience in diverse areas of Science with domain knowledge in Life Sciences and Intellectual Property. Dr. Anand is also an inventor and budding entrepreneur. A rationalist, Dr. Anand enjoys science at all levels and advocates the use of scientific methods for answering all questions and solving all problems and make common people curious and interested in understanding their worlds.

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June 27, 2017: Your weekly dose from the world of patents. The Patent Chronicle is led by Syam Anand, who has been at the core of CSG’s development and an entrepreneur himself. This section is your go to destination every week for a capsule dose on the hottest happenings in the patent world. Syam has clinically dissected out every news on the decision, the background and the impact. He is also in the process of building his scicomm team for this section. If you would like to come aboard, mail him at syam.anand@sciwri.club

China gives CRISPR patent to UC Berkeley

Impact: UC Berkeley’s patent on CRISPR has broader claims compared one of the Broad Institute’s patents that claimed a “victory” in an infringement battle at the USPTO. UC Berkeley’s application was also granted in the EU and UK. These wins are good for Doudna’s CRISPR startups, Intellia and Caribou Life Sciences and bad for Editas, which has licensed CRISPR from Broad Institute.

US Supreme Court to look at Patent Review process

Decision: The US Supreme Court has taken up an appeal by a Texas company that essentially questions the Patent Office’s right to cancel patents it previously granted.

Reason: Texas-based Oil States International Inc had previously lost a case in a lower court where it argued that patent owners have a right to a jury trial, as patents are private property and USPTO’s inter partes review process does not give them their constitutional right, as they are decided by administrative judges. The Supreme Court had earlier ruled that owners of private property who have their rights revoked have a right to a jury trial.

Impact: If the Supreme Court sides with Oil States International, it will directly question the constitutionality of the PTAB review procedure and also the larger question whether patents are private property.

STRONGER Patents Act Introduced in the US senate

Decision: Senators Chris Coons (Democrat; Delaware) and Tom Cotton (Republican; Arkansas) introduced the Support Technology & Research for Our Nation’s Growth and Economic Resilience (STRONGER) Patents Act in the US Senate.Background: Two years back, an earlier version of the Act (STRONG, without the ER) that was introduced by Sen. Coons failed to pass in the Senate. The new bill is a revised version of the old one. It is apparently aimed at strengthening the patent system by a set of proposed legislation that will gut many of the provisions in America Invents Act (AIA).Impact: The US Patent Office with the help of AIA has been pursuing to strengthen the patent system by strengthening procedures that gets rid of low quality patents. The STRONGER Patents Act wants to reverse that by making it difficult to challenge the validity of patents in the USPTO using those procedures. The proposed legislation is unlikely to go anywhere. However, it throws light on how a section of America views the patent system and where and how the validity of patents can be questioned. One major focus of the proposed legislation is the post-grant review procedures in the USPTO.

Background: Cleveland Clinic had brought an infringement suit against True Health Diagnostics LLC on the Clinic’s cardiovascular disease diagnostic test patents. The Ohio court had used the US Supreme Court’s 2012 famed Mayo decision that natural laws are not patentable to invalidate the Clinic’s patents. In essence patents that cover nothing more than the natural correlation become invalid in light of Mayo. In this case, the Ohio court ruled that the Clinic’s patents covered nothing more than a natural correlation between an enzyme and an increased risk of cardiovascular disease.

Impact: The US Supreme Court’s Mayo decision and its impact on diagnostic patents are very familiar to people familiar with intellectual property law. The latest decision on the Clinic’s patent invalidation is a case worth reading and understanding for people who are in the business of developing diagnostic tools and understanding the distinction between innovation and patentability.

Infographically speaking………

Authored by Dr Syam Anand, PhD (Indian Institute of Science, IISc; Post-Doctoral research, University of Pittsburgh School of Medicine; Faculty, University of Pittsburgh School of Medicine, Founder and US Patent Agent, Mainline Intellectual Property LLC, Ardmore, Philadelphia USA). Syam has over 20 years experience in diverse areas of Science with domain knowledge in Life Sciences and Intellectual Property. Dr. Anand is also an inventor and budding entrepreneur. A rationalist, Dr. Anand enjoys science at all levels and advocates the use of scientific methods for answering all questions and solving all problems and make common people curious and interested in understanding their worlds.

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June 13, 2017: Your weekly dose from the world of patents. The Patent Chronicle is led by Syam Anand, who has been at the core of CSG’s development and an entrepreneur himself. This section is your go to destination every week for a capsule dose on the hottest happenings in the patent world. Syam has clinically dissected out every news on the decision, the background and the impact. He is also in the process of building his scicomm team for this section. If you would like to come aboard, mail him at syam.anand@sciwri.club

USPTO director quits

Decision: Michelle Lee, director of USPTO for since 2015 submitted her resignation.

Reason: There appeared to be a disconnect between Obama-appointed Lee and the Trump administration.

Impact: Ms. Lee, had brought about many reforms in USPTO, the most prominent of which was the effectiveness with which USPTO invalidated of low quality patents. As many as one in four patents ended got invalidated in the USPTO through post-grant review processes in the PTAB. Lee had the overwhelming support of technology companies as a result of the reforms under her direction that impacted patent quality in a good way. Following Lee’s resignation, Joseph Matal was appointed acting USPTO director. Matal was the principal staff drafter of the America Invents Act. He held the Associate Solicitor position at the USPTO before being appointed the acting Director. If confirmed for the top position at the USPTO, he is a well accomplished and well poised to head USPTO.

Disney wants to block home 3D printing of trademarked figurines

Decision: Disney is seeking to patent technology that will block 3D printing of its trademarked figures such as Mickey mouse and Elsa by individuals.

Reason: Currently scanning and home 3D printing of Disney figurines cannot be prevented although Disney strictly enforces its IP rights wherever it can.

Impact: The technology as described appears to be dependent on incorporation of certain materials that will prevent scanning of the figurines. Therefore, its usefulness will be very limited on figurines that are already out there. However, scanning and printing of future Disney figurines could certainly be prevented by such technology.

Religion bound to impact certain patents in India

Background: The current administration in India has enacted a ban on sale of cattle for slaughter. It has affected sale and transport of cattle within and across state boundaries. The ruling party holds that cow is a holy animal for Hindus. Many people who are in the cattle, farm and meat trade have been hurt and many lives lost at the hands of religious mobs and armies formed to protect cows.

Affected technology: Pending patents that cover improved and more humane methods to slaughter animals. Although the claims in these patents do not specifically mention cows, the interpretation is inclusive of cows.Impact: Depends on how broad the ban on animal slaughter will become in the near future. If it is restricted to cattle, specifically cows, modifying claims to exclude cows will help the pending applications get around the barrier.

Regeneron vs Amgen anti-cholesterol drug patent war

Decision: Pending at the federal appeals court.Background: Amgen Inc. requested the court to block Sanofi and Regeneron’s sale of anti-cholesterol drug, Praluent, on patent infringement grounds. Sanofi and Regeneron on the other hand are attempting to invalidate Amgen’s patents that cover PCSK9 inhibitors, on the grounds that they improperly claim a broad monopoly. Amgen enjoyed a jury-awarded injunction on the sale of Praluent for 12 years until Sanofi and Regeneron’s appeal.Impact: Questions raised by the court and arguments presented so far appear to hint that the court may side with Sanofi and Regeneron. Irrespective of which party wins, Sanofi and Regeneron will be the real winners in the case as the damages for lost-profits and continuing infringement will be only a tiny fraction of Sanofi’s profits from sale of Praluent. This is because Amgen’s cholesterol drug Repatha serves a different patient population. Sanofi earns around 100 million USD annually from Praulent sales. A worrying aspect of injunctions against drug manufacturers is their adverse impact on gathering information on the effects of these drugs on true end points (cardiovascular events in this case) versus surrogate endpoints (lowering LDL cholesterol in this case). The PCSK9 drugs were approved on the basis of a surrogate endpoint on the condition that their sponsors continue studying their true endpoints.

Proprietary Humor:

Authored by Dr Syam Anand, PhD (Indian Institute of Science, IISc; Post-Doctoral research, University of Pittsburgh School of Medicine; Faculty, University of Pittsburgh School of Medicine, Founder and US Patent Agent, Mainline Intellectual Property LLC, Ardmore, Philadelphia USA). Syam has over 20 years experience in diverse areas of Science with domain knowledge in Life Sciences and Intellectual Property. Dr. Anand is also an inventor and budding entrepreneur. A rationalist, Dr. Anand enjoys science at all levels and advocates the use of scientific methods for answering all questions and solving all problems and make common people curious and interested in understanding their worlds.

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June 6, 2017: Your weekly dose from the world of patents. The Patent Chronicle is led by Syam Anand, who has been at the core of CSG’s development and an entrepreneur himself. This section is your go to destination every week for a capsule dose on the hottest happenings in the patent world. Syam has clinically dissected out every news on the decision, the background and the impact. He is also in the process of building his scicomm team for this section. If you would like to come aboard, mail him at syam.anand@sciwri.club

US Supreme Court interprets reselling in light of “patent exhaustion”

Decision: In a case involving Lexmark ‘s printer cartridges, the US Supreme Court ruled that Lexmark could not use the patent laws to enforce the contractual conditions it placed on the sale of cartridges. The ruling added that under the doctrine of “patent exhaustion”, once a patent holder sells an item, it could no longer control the item through the patent laws.

Reason: Lexmark had approached the court for infringement by Impression Products, over refilling and reselling of its cartridges after they are empty. Lexmark sold the cartridges under the condition that they may not be reused after the ink ran out. Impression products did just that after procuring empty Lexmark cartridges.

Impact: Since the court made it clear in their ruling that users of patented products can do what they wish with purchased items after without fear of infringement, this opens doors for businesses to engage in refurbishing and reuse of patented products without fearing infringement suits. It is good news for consumers and for the environment and bad news for patent holders as this would clearly extend the life of products beyond what they had contemplated directly affecting market shares.

Shire survives Inter Partes Review of its patent by amending claims

Decision: USPTO’s PTAB granted Shire a motion to amend its claims in an Inter Partes Review (IPR) at the board brought by Amerigen.

Reason: Amerigen had initiated the proceeding and also requested the Board to not allow Shire’s motion to amend on the grounds that Shire failed to demonstrate the patentability of a proposed substitute claim. PTAB reasoning, based on claim construction and dependency of a multiple dependent claim, was that the trial was restricted to one of the dependencies of the multiple dependent claim and removing one of the dependencies of the multiple dependent claim made the remaining claims patentable.

Impact: This is a rare case in which the PTAB allowed a motion to amend without asking the party to demonstrate the patentability of the proposed substitute claim based on Idle Free decision, which is on the list of Representative Orders, Decisions, and Notices from PTAB. The uniqueness of the decision was dependent largely on claim construction, claim dependency and as well as nature of the request for IPR, clearly something that patent agents and patent attorneys will depend on in future, instead of relying entirely on the Idle Free precedent.

International Trade Commission may punish Garmin in infringement

Decision: In an Initial Early Determination (IED), an ITC judge recommended that Garmin pay 37 million dollars to Navico.

Reason: Garmin ignored a previous cease and desist order from ITC on a case involving infringement of Navico’s patent.

Impact: If the recommendation is followed through, Garmin ends up paying the huge fine for not following ITC order to cease and desist. The EID also contents that Garmin’s “design-around” innovation to the infringed technology also infringes Navico’s patent on Sonar Technology. Navico will clearly gain an upper hand in the technology if the recommendations make it into the final ruling.

Japan leads in international patent filings

Source: A WIPO report that analyzed the addresses of inventors in close a million PCT applications filed between 2011 and 2015.Findings: The Japanese cluster had more than double the number of applications compared to the Chinese cluster that came second. US stood third and the number of applications was nearly a third of that of the Japanese cluster, putting Japan in a clear lead.

Follow through: WIPO regularly publishes Global Innovation Indices. The next one is due on June 15th.

Infographically Speaking…

Proprietary Humor

Authored by Dr Syam Anand, PhD (Indian Institute of Science, IISc; Post-Doctoral research, University of Pittsburgh School of Medicine; Faculty, University of Pittsburgh School of Medicine, Founder and US Patent Agent, Mainline Intellectual Property LLC, Ardmore, Philadelphia USA). Syam has over 20 years experience in diverse areas of Science with domain knowledge in Life Sciences and Intellectual Property. Dr. Anand is also an inventor and budding entrepreneur. A rationalist, Dr. Anand enjoys science at all levels and advocates the use of scientific methods for answering all questions and solving all problems and make common people curious and interested in understanding their worlds.

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May 23, 2017: Your weekly dose from the world of patents. The Patent Chronicle is led by Syam Anand, who has been at the core of CSG’s development and an entrepreneur himself. This section is your go to destination every week for a capsule dose on the hottest happenings in the patent world. Syam has clinically dissected out every news on the decision, the background and the impact. He is also in the process of building his scicomm team for this section. If you would like to come aboard, mail him at syam.anand@sciwri.club

Strict limits on patent litigation venues in future

Decision: The US Supreme Court ruled unanimously in favor of TC Heartland in the case against Heinz preventing Heinz from litigating in Delaware.

Reason: The practice of selecting friendly favorable venues was an irritant for majority of patent owners. The court had realized the far-reaching consequences of the case and taken pains to carefully weigh the facts before delivering it’s ruling.

Impact: The case was high profile and closely followed by everyone. Suing for infringement in friendly and favorable venues such as Delaware and the Eastern District of Texas will be impacted in light of this ruling. It is a big win against Trolls favor the two venues.

Aurobindo Pharma secures unusual injunctive relief against Mylan

Decision: The Federal circuit granted injunctive relief for Aurobindo in the infringement case brought against it by Mylan on Isosulfan Blue (IB).Reason: The court felt that Aurobindo is likely to prevail on merits, will likely suffer irreparable harm in the absence of such relief, the balance of equities favor it, and it is in public interest.Impact: The bigger impact of the ruling comes from the test that was applied by the court to provide relief. Instead of a function-way-result test (product performing substantially the same function in substantially the same way to obtain the same result), the court used the insubstantial differences test (accused product or process is substantially different from the patented one) stating that is more appropriate for chemical arts. The ruling could be a trendsetter giving as much importance to the process as the product. This could bode well for the chemical arts. The relief provided for Aurobindo is a motivation for others interested parties also to strategize their assets.

SC to weigh in on Inter Partes Review practice

Decision: The US supreme court decided to take up a case that will review whether USPTO’s PTAB should issue written decisions on all of the claims challenged by a third party in Inter Partes Reviews or just on the claims PTAB chose to review.

Reason: The PTAB usually grants a review based on merits of the likelihood that the petitioner would prevail with respect to at least one claim. In the process, not all the claims are necessarily chosen for review. In scenarios where the petitioner successfully gets the PTAB to invalidate some of the claims in a patent under review, the PTAB issues written decisions only on those that were reviewed in the procedure.

Impact: If it is ruled that PTAB should issue written decisions on all the claims in the contested patent, it will put additional burden on the Board. For the petitioner the written decisions on all the claims will be a useful resource if the Board’s decision is questioned later in the court by the patent owner.

Abbvie’s Humira patent invalidated

Impact: The patent was set to expire in 2022. Humira brings in multibillion dollars to Abbvie. The impact of the ruling was immediate as the stocks of Abbvie dived and Coherus gained. Coherus is coming up with biosimilars to the Humira. In light of the ruling, they can use the same drug regimen for treatments. Abbvie has other patents that protect the formulations till 2022. Coherus will have to figure out a strategy to deal with the remaining patents that survived while marketing their biosimilar. Needless to say, there are others also wanting to cash in on this turn of events.

Infographically Speaking…..

Authored by Dr Syam Anand, PhD (Indian Institute of Science, IISc; Post-Doctoral research, University of Pittsburgh School of Medicine; Faculty, University of Pittsburgh School of Medicine, Founder and US Patent Agent, Mainline Intellectual Property LLC, Ardmore, Philadelphia USA). Syam has over 20 years experience in diverse areas of Science with domain knowledge in Life Sciences and Intellectual Property. Dr. Anand is also an inventor and budding entrepreneur. A rationalist, Dr. Anand enjoys science at all levels and advocates the use of scientific methods for answering all questions and solving all problems and make common people curious and interested in understanding their worlds.

(May 16, 2017) Your weekly dose from the world of patents. The Patent Chronicle is led by Syam Anand, who has been at the core of CSG’s development and an entrepreneur himself. This section is your go to destination every week for a capsule dose on the hottest happenings in the patent world. Syam has clinically dissected out every news on the decision, the background and the impact. He is also in the process of building his scicomm team for this section. If you would like to come aboard, mail him at syam.anand@sciwri.club

Bounty on Trolls

Decision: Tech firm Cloudware announced bounties (20,000$ and 50,000$) for invalidating patents owned by Blackbird, a company formed by lawyers that files law suits against tech and retail firms.

Reason: Blackbird sued Cloudware for one of the patents they own. Couldware was convinced that Blackbird was behaving like a patent troll. Therefore they decided to announce a bounty, not just on the Blackbird patent that is the basis of the law suit against them, but for every patent Blackbird lists on their website.

Impact: Patent invalidation in courts and in the USPTO is common. Usually any prior art that discloses the crux of the invention before the priority date of the patent is sufficient to get a patent invalidated. The bounty on Blackbird patents could attract prior art search experts to hunt for information that has the potential to invalidate Blackbird patents. It gives more bangs for buck for all parties except Trolls.

Pittsburgh’s Renovacare patent challenged in USPTO

Decision: Avita, an Australian firm successfully filed an inter partes review in the USPTO seeking to invalidate Renovocare’s US Patent No. 9,610,430.

Reason: Avita believes that USPTO should never have granted the patent in the first place, in light of Avita’s patent.

Impact: Inter partes review is a post grant challenge mechanism at the USPTO that banks on prior art that are patents and publications while seeking to invalidate a granted US patent. USPTO’s PTAB will review the challenge. US patent 9,610,430 discloses and claims a “Device for cell spraying, manufacturing of the device, method for spraying with the device and a cell suspension sprayed with the device”. According to Renovocare’s description, the device can be successfully used to spray a patient’s own stem cells onto burns and wounds for rapid self-healing. The device patent has a term till 2035. It is doubtful whether Avita’s patent will be valid prior art for Renovacare’s device.

Post-doc sues Professor for patent royalties

Decision: An ex-Harvard University post-doctoral scholar sued his mentor for patent royalties on CortistatinA patent, that fetched millions in royalties.Reason: The professor had excluded the researcher. It is alleged that he was assured of inclusion in the patent and was the only one working on the project when it was initiated.Impact: Definitions for inventorship in a patent application or patent and authorship in an academic publication are different. Anyone contributing to the concept of an invention that is claimed in a patent has the right to be an inventor. If evidence indicates that the researcher contributed to the concept and not merely worked on the project, he could win the right to the royalties on the patent.

2017 Revision of Chinese Patent Office guidelines

Reason: The Chinese Patent Office had made several amendments to their patent law and sought discussions before finalizing them. At the conclusion of these discussions, many revisions were finalized that would have a lasting impact on access to patent filing data, consideration of supplemental information during examination, invalidation procedures, and patentable subject matter.Impact: The impact of the changes will be huge especially for three areas. The subject areas and key amendments are listed in the source provided in the link. In Biotech/Chem, “examiners are explicitly permitted to consider supplemental experimental data submitted by the applicant during prosecution when arguing against a lack of sufficient disclosure rejection”, if they meet certain criteria. Business methods are no longer considered “mental activity” that are not patent eligible, if they meet certain criteria. In Software, computer softwares are now patent eligible if they meet certain criteria.

JD Supra’s PTAB reports on Life Science Patents

Importance: The validity of granted US patents may be questioned both in the USPTO and in the US court system. Many cases are taken up through post-grant challenge procedures available at the USPTO. Life Science and Pharma being an important financial/innovation sector, it will be great to have a handle on such activities available on a periodical basis, especially for people who are employed or invested directly or indirectly in that sector.Impact: The PTAB reports on Life Science Patents from JD Supra appears be a worthwhile place for investors and consultants to understand the risks and nature of Patent proceedings and which companies are good at taking care of their IP and which companies have their IP rights being questioned. It may hint at emerging trends and chances of some patents getting invalidated over others. Added attraction- it is free.

Authored by Dr Syam Anand, PhD (Indian Institute of Science, IISc; Post-Doctoral research, University of Pittsburgh School of Medicine; Faculty, University of Pittsburgh School of Medicine, Founder and US Patent Agent, Mainline Intellectual Property LLC, Ardmore, Philadelphia USA). Syam has over 20 years experience in diverse areas of Science with domain knowledge in Life Sciences and Intellectual Property. Dr. Anand is also an inventor and budding entrepreneur. A rationalist, Dr. Anand enjoys science at all levels and advocates the use of scientific methods for answering all questions and solving all problems and make common people curious and interested in understanding their worlds.

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(May 08, 2017) Your weekly dose from the world of patents. The Patent Chronicle is led by Syam Anand, who has been at the core of CSG’s development and an entrepreneur himself. This section is your go to destination every week for a capsule dose on the hottest happenings in the patent world. Syam has clinically dissected out every news on the decision, the background and the impact. He is also in the process of building his scicomm team for this section. If you would like to come aboard, mail him at syam.anand@sciwri.club

Section 1498 threat to Gilead Hepatitis C medicine

Decision: The state of Louisiana is planning to use a Federal Law that goes back to 1910 that allows government regulators to appropriate inventions and use the products for public good.

Reason: Antivirals for Hepatitis C such as Sovaldi and Harvoni are made by Gilead are turning out to be expensive for Louisiana. Patent laws are in the way of procuring drugs from generic manufacturers. Louisiana wants the Trump administration to consider using the old law to negotiate affordable prices.

Impact: It is reported that top academic and legal health specialists are of the opinion that Louisiana pursue this avenue. At the same time, it is doubtful whether the Trump administration will support Louisiana State in this effort. It would need the current Health and Human Services Secretary to act. His record indicates otherwise. That said, a decent threat of invoking the law could bring Gilead to the negotiating table.

Reason: The court found that the claims were obvious in the light of prior art.

Impact: NantKWest is struggling since 2016 from a stock sell-off that wiped out nearly half of the company’s value. The hope that remained was the uniqueness of the company’s approach to cure cancer employing Natural killer cells. The court decision reduces the prospects of a rebounce for NantKWest’s fortunes.

Fidget Spinner inventor let patent expire in 2005

Reason: The inventor simply did not have money to pay the fees.Impact: The inventor is left with no rights to an invention that has become very popular. Sadly, it appears that she made no profit, while others do, out of a toy that she originally made for her 7-year old daughter. It also appears that she is failing to make her ends meet in spite of the obvious success of her invention in the market. The toy has very become popular (almost to extent of becoming annoying in class rooms as students “fidget” with them all the time) and also finds potential applications in therapy for conditions such as ADHD.

New licenses strengthen Novartis CAR-T

Reason: Novartis is rushing its CTL019 towards approval following designation of CTL019 (tisagenlecleucel) as a breakthrough technology by the FDA for potential treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). They needed the license to allow them access to the technologies owned by Bluebird Celyad to further develop the CAR-T technology.

Impact: CAR-T has been a high-traffic deal-making arena. The acquiring of IP rights to Bluebird and Celyad patents will allow Novartis to pursue CAR-T based pipelines for DLBCL and other conditions, giving Novartis more freedom to operate in this area. The license allows Novartis to further develop the technologies.

PTAB cites inequities on patent owner while rejecting follow-up challenges to the same patent

Decision: The USPTO PTAB declined to institute an inter partes review on a request by Akamai technolgies Inc. against Limelight Networks Inc.

Reason: Inter partes review is a post-grant challenge mechanism that may be used to question the validity of patents in the USPTO. The PTAB that deals with post-grant processes at the USPTO, felt that Akamai used PTAB’s decision just a month earlier on a similar challenge to the same Limelight Networks to guide preparation of the new challenge. PTAB stated that granting a new challenge prepared using PTAB’s earlier unfavorable judgment as a guide would be unfair to the patent owner. Further, it is PTAB’s stand that the process should not be used to make repetitive attacks on a patent.

Impact: The challenge will most likely shift venue into the courts where the two companies have been fighting several battles centered on content delivery networks (CDNs).

Authored by Dr Syam Anand, PhD (Indian Institute of Science, IISc; Post-Doctoral research, University of Pittsburgh School of Medicine; Faculty, University of Pittsburgh School of Medicine, Founder and US Patent Agent, Mainline Intellectual Property LLC, Ardmore, Philadelphia USA). Syam has over 20 years experience in diverse areas of Science with domain knowledge in Life Sciences and Intellectual Property. Dr. Anand is also an inventor and budding entrepreneur. A rationalist, Dr. Anand enjoys science at all levels and advocates the use of scientific methods for answering all questions and solving all problems and make common people curious and interested in understanding their worlds.